MAUDE Adverse Event Report: COOK INC MICROPUNCTURE TRANSITIONLESS PEDAL ACCESS SET; DYB INTRODUCER, CATHETER

Model Number N/A

Device Problems Kinked (1339); Split (2537)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/22/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.

Event Description

A micropuncture transitionless pedal access set was used in a lower extremity retrograde pedal intervention.It was reported that access was gained for retrograde tibial intervention by ultrasound.The micro-puncture wire was fed thru the needle and the needle was removed.The micro-puncture sheath was inserted over the wire and the dilator was removed, then the micro-puncture wire was removed and another manufacturers.014 wire was inserted.A cook.018 cxi was inserted over the wire but could not advance past the hub of the micro-puncture sheath.The sheath was removed and a kink in the sheath was visible.The tip of the micro-puncture sheath was also reported to have damage.A second micro-puncture access sheath was used to complete the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Corrected information: date rec¿d by mfr.Investigation - evaluation: a review of the complaint history, drawings, device history record, documentation, specifications, quality control, and visual inspection of the returned device was conducted during the investigation.The outer coaxial catheter from the micropuncture transitionless pedal access set was returned for investigation.Visual examination of the returned sheath confirmed the surface to be kinked (twisted) in two places.The first noted kink was found right under the hub.The second noted kink was 6 millimeters (mm) from the proximal fitting.The tip was visibly damaged (wrinkled and split) under magnification; it appears the tip has been split.No other damage to the surface of the sheath was noted.No blood/ biological matter was present on the sheath.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that could contribute to this failure mode.A complaint history search revealed that there was one other reported complaint for this lot number, which was created as a result of this event to capture kinking observed on the sheath.Based on the information provided, examination of the returned product, and the results of our investigation, a definite root cause could not be determined.Per the quality engineering risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.

• Brand Name: MICROPUNCTURE TRANSITIONLESS PEDAL ACCESS SET
• Type of Device: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6978153
• MDR Text Key: 90955652
• Report Number: 1820334-2017-03638
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00827002029729
• UDI-Public: (01)00827002029729(17)180603(10)5928445
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: MPIS-401-PEDAL-NT-U-SST
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1