MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC ENVOY 6F GUIDING CATHETERS; PERCUTANEOUS CATHETER

Catalog Number 67025690B

Device Problems Split (2537); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/04/2017

Event Type  malfunction  

Manufacturer Narrative

This event was initially reported on 5/8/2017; however, did not meet mdr criteria until 5/30/2017 when it was reported that the catheter was cracked/split.The device was returned for analysis; however, the analysis has not yet been completed.Additional information will be submitted within 30 days of receipt.

Event Description

As reported by a healthcare professional an envoy catheter (67025690b/ 17641208) would not advance up the cordis sheath, and when it could advance it was stiff and caused the envoy to break (cracked/split) at the distal tip.The same issue occurred 2 days running (additional complaint added).This hospital has used the same setup including the catheter and sheath and has had this issue occur a few times in the last calendar year; however, all complaints were reported to the manufacturer.The device was used as per the ifu, and a flush had been maintained.It was reported that the catheter and sheath was available for analysis.

Manufacturer Narrative

Conclusion: as reported by a healthcare professional an envoy catheter ((b)(4)) would not advance up the cordis sheath, and when it could advance it was stiff and caused the envoy to break (cracked/split) at the distal tip.The device was used as per the ifu, and a flush had been maintained.It was reported that the catheter and sheath was available for analysis.A non-sterile envoy 6f, xb mpc 90cm was received inside an unknown pouch inside of a plastic bag.No damages were noted on hub of the envoy.The envoy body was inspected and it was found kinked at 45.7 cm from the proximal end of hub.Compressed sections at 3.8 cm from the distal end tip.Some waves were found on the products, but this can occur during the handling of the units when these were return for evaluation.The id and od from the envoy were measured and were found within specification.The functional analysis was performed.The envoy received was flushed out using a lab sample syringe, and the water came out from the distal end of the device.A 0.038¿ guide wire lab sample was introduced into the envoy and it advance smoothly until the envoy distal tip and resistance was found when the guidewire was passed through kink sections and compressed section found on body.The envoy was introduced into the cordis lab sample cannula and it advance until the cannula distal tip end; however, resistance was felt at the brite tip fuse area.However, it passed through the entire brite tip fuse area of the cannula lab sample.A review of the manufacturing documentation associated with this lot 17641208 presented no issues during the manufacturing or inspection process that can be related to the reported complaint.The distal tip catheter damage and the inability to advance the catheter through the sheath were not confirmed.The kinked and compressed damages found on the received device were apparently caused by applying excessive force, but it could not be conclusively determined.These defects could not be related to the manufacturing process and procedural factors appear to have contributed to have this damage.Inspections are in place that prevents this kind of failure from leaving the manufacturing facility.Neither the analysis nor the dhr suggest that the failure reported by the costumer could be related to the manufacturing process.; therefore, no corrective action will be taken at this time.

Manufacturer Narrative

Initial reporter updated.The company employee reported on behalf of the facility.

• Brand Name: ENVOY 6F GUIDING CATHETERS
• Type of Device: PERCUTANEOUS CATHETER
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• Manufacturer Contact: karen anigbo ; circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580 ; 5088288374
• MDR Report Key: 6644942
• MDR Text Key: 77790041
• Report Number: 3008264254-2017-00083
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 10886704031727
• UDI-Public: (01)10886704031727(17)191231(10)17641208
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K000715
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 67025690B
• Device Lot Number: 17641208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1