MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC (MEXICO) ENVOY 6F, MPD 100CM; PERCUTANEOUS CATHETER

Catalog Number 67025800

Device Problem Material Separation (1562)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 12/05/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint: (b)(4).Concomitant med products due to character limitation: v-18 (boston scientific) guidewire, avigo (medtronic) micro-guidewire, 2.0x15mm gateway (boston scientific) balloon.The product is available for evaluation and testing; however, it has not been received to date.Additional information will be submitted within 30 days of receipt.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.

Event Description

As reported by a healthcare professional, during a balloon angioplasty of the basilar artery, a 6f envoy (67025800/30048285) guide catheter became bent and separated in the patient.After the tip of 6f envoy catheter reached the v2 end position of right vertebral artery via a v-18 (boston scientific) guidewire, the guidewire was removed.An avigo (medtronic) micro-guidewire was placed to deliver the 2.0 x 15mm gateway (boston scientific) balloon through the envoy catheter, but it was difficult to advance.It was discovered via fluoroscopy that the envoy guide catheter was bent.While attempting to pull the catheter back, the envoy catheter separated and fell into the vessel.The fallen part was pulled out through bilateral femoral artery approach, and the surgery was completed successfully with another device.It was reported that the procedure was completed with patient injury; however, the specific injury was not specified.The surgery was delayed five hours due to the event.After the recovery treatment in the neurointensive care unit, the patient was awake and able to perform some activities.The complaint product was new and stored/handled according to the labeling instructions/instructions for use (ifu) and the device had been packaged securely as expected.There was no damage to the catheter packaging or shipping container.The procedure was conducted in accordance with the ifu and a constant flush was maintained.The product will be returned for evaluation.Other products used as a system with the complaint device will be returned if available.No further information could be obtained.

Manufacturer Narrative

Product complaint#: (b)(4).Updated sections: pma/510k, if follow-up, what type, device evaluated by mfr.[complaint conclusion].As reported by a healthcare professional, during a balloon angioplasty of the basilar artery, a 6f envoy (67025800/30048285) guide catheter became bent and separated in the patient.After the tip of 6f envoy catheter reached the v2 end position of right vertebral artery via a v-18 (boston scientific) guidewire, the guidewire was removed.An avigo (medtronic) micro-guidewire was placed to deliver the 2.0 x 15mm gateway (boston scientific) balloon through the envoy catheter, but it was difficult to advance.It was discovered via fluoroscopy that the envoy guide catheter was bent.While attempting to pull the catheter back, the envoy catheter separated and fell into the vessel.The fallen part was pulled out through bilateral femoral artery approach, and the surgery was completed successfully with another device.It was reported that the procedure was completed with patient injury; however, the specific injury was not specified.The surgery was delayed five hours due to the event.After the recovery treatment in the neurointensive care unit, the patient was awake and able to perform some activities.The complaint product was new and stored/handled according to the labeling instructions/instructions for use (ifu) and the device had been packaged securely as expected.There was no damage to the catheter packaging or shipping container.The procedure was conducted in accordance with the ifu and a constant flush was maintained.No further information could be obtained.A non-sterile 6f envoy mpd 100cm guide catheter was received inside of a pouch in two separate pieces.Visual inspection was conducted, and residues of dried blood were noted on the hub, body, and distal end of the catheter.The body was found kinked at 2, 3.5, 5.5,7.0, 11.5, 12.0, 17.0 ,21.0, 23.0,61.0 and 87.0 cm from the distal end.The catheter body was found broken and twisted at 23 cm from the distal end.The distal tip was inspected, and no damage was observed.There were no other visual anomalies observed during the visual inspection.Functional analysis could not be performed since it was not possible to insert a guidewire through the distal tip of the envoy to the distal end due to the device separation.The inner diameter (id) and outer diameter (od) were measured and were found within specification.A review of manufacturing documentation associated with this lot revealed that one unit was rejected due to kinks and it could be related to the reported complaint; however, the device history record review confirmed that the rejected unit was properly segregated and discarded.No other issues were noted that were considered potentially related to the reported complaint.The customer report that the catheter was kinked and separated was confirmed during visual inspection.The customer report of resistance/friction could not be evaluated due to the separated condition of the returned device.Injury to the patient and catheter kink/bent with possible separation are known potential events associated with the use of the envoy catheter.The root cause of the damage could not be conclusively determined via product analysis, but the damages noted to the returned device are indicative of the application of excessive force, possibly in an attempt to overcome the reported resistance.Excessive force and torqueing having been applied to the device may have contributed to the kinking and separation.Based on the minimal information available, it is not possible to determine the procedural situation that led to the application of excessive force or torqueing; however, the presence of dried blood on the hub, shaft, and distal tip suggest an insufficient flush may have been maintained through the device which could lead to resistance within the device caused by backflow of blood.The instructions for use (ifu) recommends a continuous heparinized saline flush be maintained between the envoy guide catheter and any intraluminal device passed coaxially through it.The ifu also cautions: ¿if strong resistance is met during manipulation, discontinue the procedure and determine the cause of the resistance before proceeding.If the cause of the resistance cannot be determined, withdraw the catheter.Should the guiding catheter shaft become severely kinked, withdraw the entire system (guiding catheter, guidewire, and catheter sheath introducer).¿ the returned device was found to be twisted, which is consistent with the ifu warning that torqueing the catheter excessively while kinked may cause damage which could result in possible separation along the catheter shaft.Neither the product analysis nor the device history review suggests that the failure could be related to the manufacturing process of the unit.Assignment of root cause for the event remains speculative and inconclusive, based on the minimal information provided and the evidence presented by the returned sample; however, it is possible that clinical and procedural/handling factors, including patient anatomy/vessel characteristics, device manipulation, and inadequate flush, may have contributed to the reported failure and damages noted on the returned system.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective/preventive action may be triggered at a later time.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.

Manufacturer Narrative

Product complaint #: (b)(4).The purpose of this mdr submission is to report the results of the device history record review.A review of the manufacturing documentation associated with this lot revealed that one unit was rejected due to kink defect.However, the device history record review confirmed that the rejected unit was properly segregated and discarded.No other issues were noted that were considered potentially related to the reported complaint.The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.Additional information will be submitted within 30 days of receipt.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: ENVOY 6F, MPD 100CM
• Type of Device: PERCUTANEOUS CATHETER
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC (MEXICO); circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580
• MDR Report Key: 8171443
• MDR Text Key: 130617328
• Report Number: 1226348-2018-00797
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 10886704031734
• UDI-Public: 10886704031734
• Combination Product (y/n): N
• PMA/PMN Number: K000715
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 67025800
• Device Lot Number: 30048285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2019
• Date Manufacturer Received: 01/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 69