MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC (MEXICO) PROWLER SELECT PLUS 150/5CM; CATHETER, CONTINOUS FLUSH

Catalog Number 606S255X

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2018

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).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.This is one of two products involved with the reported complaint and the associated manufacturer report numbers are 1226348-2018-00801 & 3008264254-2018-00539.

Event Description

As reported by a healthcare professional, during a stent-assisted coil embolization of an intracranial aneurysm, after the physician placed the unspecified guide catheter and prowler select plus 150/5cm (606s255x/17541950) microcatheter in the correct position, he inserted the 4.5mm x 22mm enterprise (enc452212/10827625) stent vascular reconstruction device but found that it was difficult to push.The microcatheter was removed from the patient and the physician discovered a fold near the catheter tip.The microcatheter was replaced and the procedure was completed successfully without further incident.No patient complications occurred as a result of the event.The surgery was not delayed due to the event.The products were new and stored and handled according to the labeling instructions.The products were packaged securely as expected.No apparent damage was noted to the catheter packaging or shipping container.The procedure was conducted in accordance with the instructions for use (ifu) and a constant flush was maintained.The products will be returned for evaluation.No further information could be obtained.

Manufacturer Narrative

Product complaint # (b)(4).[complaint conclusion].As reported by a healthcare professional, during a stent-assisted coil embolization of an intracranial aneurysm, after the physician placed the unspecified guide catheter and prowler select plus 150/5cm (606s255x/17541950) microcatheter in the correct position, he inserted the 4.5mm x 22mm enterprise (enc452212/10827625) stent vascular reconstruction device but found that it was difficult to push.The microcatheter was removed from the patient and the physician discovered a fold near the catheter tip.The microcatheter was replaced and the procedure was completed successfully without further incident.No patient complications occurred as a result of the event.The surgery was not delayed due to the event.The products were new and stored and handled according to the labeling instructions.The products were packaged securely as expected.No apparent damage was noted to the catheter packaging or shipping container.The procedure was conducted in accordance with the instructions for use (ifu) and a constant flush was maintained.No further information could be obtained.A non-sterile prowler select plus was received coiled inside of a pouch.Upon receipt of the complaint device, a visual inspection was conducted.The catheter was found compressed/kinked at 3 and 138cm from the distal end.There were no visual anomalies observed during the visual inspection.The device was then inspected under microscope and the compressed/kinked condition was confirmed.After the visual inspection was conducted, the inner diameter (id) and outer diameter (od) of the microcatheter were measured and were found within specification.Functional analysis could not be performed with the returned enterprise device because the delivery wire was separated; however, a 0.018¿ lab sample guidewire was introduced into the microcatheter hub and advanced through the catheter.Slight friction was encountered when the guidewire was advanced through the compressed/kinked sections of the catheter.A review of the manufacturing documentation associated with this lot revealed that two units were rejected due to scrunch defect and serious body and distal end damage.However, the device history record review confirmed that the rejected units were properly segregated and discarded.No other issues were noted that were considered potentially related to the reported complaint.The customer report of catheter kinked/bent was confirmed during visual inspection.The catheter was found compressed/kinked at 3 and 138cm from the distal end.The customer report of inner lumen resistance/friction was confirmed during functional analysis.The resistance encountered during advancement may have been related to the compressed/kinked condition noted on the returned device; however, the exact circumstances surrounding the observed damage to the catheter cannot be determined.It is also possible that excessive force was applied to the device, possibly in an attempt to overcome the reported resistance.100% of devices are inspected in-process for kinks and other damage.In addition, 100% of devices are inspected after pouching for visible damage or defects.Therefore, it is very unlikely that the device left the manufacturing facility with the observed damage.Catheter kinking has been investigated.The instructions for use cautions users to inspect for kinks and bends, or other signs of damage prior to and during use.Any product with damage is not to be used.Catheter kinking during clinical use is a known and common occurrence and is typically related to anatomy, technique, physician skill, and vessel tortuousity.If the operator encounters kinking or damage during clinical use, they are clinically trained to immediately discontinue manipulations and remove the product.Resistance/friction is a known potential failure associated with the use of the device.The ifu contains several cautions relating to this situation, including instructions for troubleshooting the situation should it be encountered during use.The ifu cautions: ¿if strong resistance is met during manipulation, discontinue the procedure and determine the cause of resistance before proceeding.If the cause of resistance cannot be determined, withdraw the catheter and guidewire as a system.Do not use a catheter that has been damaged in any way.Damaged catheters may rupture causing vessel damage or tip detachment during the procedure.¿ neither the device history record review nor the product analysis suggests that the reported failures 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 device; however, it is possible that procedural and handling factors, including device manipulation, may have contributed to the reported failure.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.This is one of two products involved with the reported complaint and the associated manufacturer report number is 1226348-2018-00801.

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 two units were rejected due to the defects scrunch and serious damage (body and distal end); however, the device history record review confirmed that the rejected units were 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.This is one of two products involved with the reported complaint and the associated manufacturer report number is 1226348-2018-00801.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: PROWLER SELECT PLUS 150/5CM
• Type of Device: CATHETER, CONTINOUS FLUSH
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC (MEXICO); circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580
• MDR Report Key: 8174466
• MDR Text Key: 131384621
• Report Number: 3008264254-2018-00539
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 10886704028888
• UDI-Public: 10886704028888
• Combination Product (y/n): N
• PMA/PMN Number: K021591
• 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: 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 606S255X
• Device Lot Number: 17541950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2019
• Initial Date Manufacturer Received: 12/05/2018
• Initial Date FDA Received: 12/18/2018
• Supplement Dates Manufacturer Received: 01/02/2019; 01/17/2019
• Supplement Dates FDA Received: 01/16/2019; 01/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1