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

Model Number G47944

Device Problem Material Separation (1562)

Patient Problems No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

As reported, during an unknown procedure, the cannula included in a micropuncture transitionless access set separated.As the physician withdrew the dilator and wire guide, the cannula separated in the brachial artery.The patient was "non-dialysis" and the anatomy was not calcified.Resistance was not encountered.The device was retrieved via a surgical procedure involving a small incision and "clip out".There were no adverse effects to the patient.

Event Description

There is no new patient or event information to report.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Description of event: as reported, during an unknown procedure, the cannula included in a micropuncture transitionless access set separated.As the physician withdrew the dilator and wire guide, the cannula separated in the brachial artery.The patient was "non-dialysis" and the anatomy was not calcified.Resistance was not encountered.The device was retrieved via a surgical procedure involving a small incision and "clip out".Investigation ¿ evaluation.A visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, drawings, the instructions for use, manufacturing instructions, and quality control data.One 4fr mpis device returned, used and separated.The outer catheter has separated.The 1st separated segment includes the hub and was 1.5cm of tubing.The 2nd segment measured 8.8cm long.Separation sites were ragged, and the distal endhole was compressed.No other issues were identified.There was no evidence from device analysis that the complaint device was manufactured out of specification.A review of the device history record found no non-conformances related to the reported failure mode.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.A review of complaint history records shows no other complaints associated with the complaint device lot.The instructions for use (ifu), states that the complaint device is intended for the placement of wire guides up to 0.038 inch diameter into the peripheral vascular system when a small 21g needle stick is desired.The ifu also states the following: ¿when inserting, manipulating or withdrawing a device through an introducer, always maintain introducer position.¿ and ¿do not attempt to insert or withdraw the wire guide and/or introducer if resistance is felt.¿ potential adverse events listed in the ifu include catheter embolism.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.Cook has concluded component failure without any design of manufacturing issue contributed to this incident.Per the supplier investigation there were no indications that manufacturing issues caused this failure.Per the quality engineering risk assessment, no further action is warranted.Cook will continue to monitor this device via the complaints database for similar complaints.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.

• Brand Name: MICROPUNCTURE TRANSITIONLESS ACCESS SET
• Type of Device: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11029224
• MDR Text Key: 222094367
• Report Number: 1820334-2020-02330
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00827002479449
• UDI-Public: (01)00827002479449(17)220530(10)9775866
• Combination Product (y/n): N
• PMA/PMN Number: K171275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2022
• Device Model Number: G47944
• Device Catalogue Number: MPIS-401-NT-U-SST
• Device Lot Number: 9775866
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2021
• Date Manufacturer Received: 05/11/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention