MAUDE Adverse Event Report: COOK INC PERFORMER INTRODUCER; DYB INTRODUCER, CATHETER

Model Number G08957

Device Problems Split (2537); Scratched Material (3020)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during a percutaneous transluminal angioplasty (pta), the tip of the performer introducer sheath split/ scratched upon insertion due to high calcification in the patient's vessel.The sheath was placed in the patient's left leg.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

This report includes information known at this time. a follow-up report will be submitted should additional relevant information become available.

Manufacturer Narrative

Investigation ¿ evaluation: a review of the complaint history, device history record, manufacturing instructions, quality control, and a visual inspection of the returned devices were conducted during the investigation.The visual inspection of the returned devices noted no damage on the surface of the sheaths or dilators, except for damage to the distal tip of the sheaths.The inner and outer diameters of both sheaths were measured, and all attributes were within specifications.Additionally, a document-based investigation was performed.There is no evidence to suggest the finished products were not made to specifications.Numerous design verification and validation activities have been performed to ensure that these devices meet design requirements.Review of the device history record of the finished product shows one nonconforming event that could contribute to this failure mode.The affected part was reworked prior to completion of the work order.A complaint history search revealed that there were no other reported complaints for this lot number.Per manufacturing quality control documentation, the sheath distal tip is inspected and confirmed to be sanded and free of rough edges.Based on the information provided, the examination of the returned products, and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment, no further action is required.

• Brand Name: PERFORMER INTRODUCER
• 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: 7135913
• MDR Text Key: 95538252
• Report Number: 1820334-2017-04616
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00827002089570
• UDI-Public: (01)00827002089570(17)200711(10)7975700
• Combination Product (y/n): N
• 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,Followup
• Report Date: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G08957
• Device Catalogue Number: RCFW-14.0-38-30-RB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1