MAUDE Adverse Event Report: COOK INC INDY OTW VASCULAR RETRIEVER; MMX DEVICE, PERCUTANEOUS RETRIEVAL

Catalog Number INDY-8.0-35-55-40

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/24/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a piece of hair was found inside the sterile packaging of an indy otw vascular retriever.

Event Description

Additional information regarding event details was received on 10mar2021.The customer confirmed that the product was pulled to set up for a case/procedure.The patient was not in the room at the time.The procedure was completed using additional items/devices in stock.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Manufacturer Narrative

Investigation ¿ evaluation.On 08mar2020 cook became aware of an incident where foreign matter was noted in the complaint device indy otw vascular retriever "rpn: indy-8.0-35-55-40 lot: 13468682".The issue was discovered at usc university hospital in los angeles, ca.The procedure was completed using additional device in stock.A review of documentation including device history record, instructions for use (ifu), manufacturing instructions and quality control, as well as a visual inspection of the returned device was conducted during the investigation.One sealed device was returned for evaluation.A visual inspection found a hair like fiber in the pouch.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) found that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record (dhr) for lot 13468682 found no nonconformances that could have contributed to the reported failure mode.It should be noted that there were no other complaints associated with this lot.The instructions for use (ifu), provides the following information related to the reported failure mode: instructions for use: t_indyotw_rev5 included with the device states "do not use the product if there is doubt as to whether the product is sterile".Based on the information provided, examination of the returned product and the results of our investigation, a definitive cause for the failure was related to the manufacturing and packaging of the device.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.We will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.

• Brand Name: INDY OTW VASCULAR RETRIEVER
• Type of Device: MMX DEVICE, PERCUTANEOUS RETRIEVAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11485845
• MDR Text Key: 244409592
• Report Number: 1820334-2021-00947
• Device Sequence Number: 1
• Product Code: MMX
• Combination Product (y/n): N
• PMA/PMN Number: K160593
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 04/28/2021

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: No Information
• Device Expiration Date: 10/05/2023
• Device Catalogue Number: INDY-8.0-35-55-40
• Device Lot Number: 13468682
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2021
• Initial Date Manufacturer Received: 03/08/2021
• Initial Date FDA Received: 03/15/2021
• Supplement Dates Manufacturer Received: 03/10/2021; 04/15/2021
• Supplement Dates FDA Received: 03/25/2021; 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1