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

Catalog Number MPIS-401-10.0-SC-SST

Device Problems Disconnection (1171); Material Separation (1562); Difficult to Advance (2920)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Date 10/30/2017

Event Type  Injury  

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 an arteriotomy, the 4fr micropuncture transitionless stiffened cannula access set fell apart when the physician attempted to access the right common femoral artery.It was noted that there had been multiple accesses of this groin site prior to the procedure as there were abbott starclose closure devices visible under fluoroscopy, and the patient had a heavily scarred groin.The physician additionally reported that the micropuncture introducer was difficult to advance.Upon withdrawal of the micropuncture introducer, the hub disconnected from the catheter.The catheter was attempted to be removed with the assistance of hemostat forceps.Upon further inspection, it was discovered that approximately half of the catheter was missing.The right side was abandoned, and a contralateral arteriotomy was done to proceed with the exam.An arteriogram was performed, and the physician determined the remaining catheter portion was not in the artery nor was it visible in the soft tissue; the portion remained within the patient¿s anatomy.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Investigation - evaluation: a review of the complaint history, dimensional verification, device history record, documentation, specifications, quality control, and visual inspection of the returned device was conducted during the investigation.The outer diameter of the micropuncture transitionless stiffened cannula access set was within specification.There was 5 millimeters (mm) of tubing attached to the internal portion of the hub.There were approximately 5.5 centimeters (cm) of the outer catheter separated from the device.Based on the information provided, examination of the returned product, and the results of our investigation, a definite root cause could not be determined; however, it is possible that the patient's heavily scarred anatomy contributed to this event.Per the quality engineering risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.

Manufacturer Narrative

Investigation - evaluation: a preliminary review of the complaint history, dimensional verification, device history record, documentation, specifications, quality control, and visual inspection of the returned device was conducted during the investigation.One used micropuncture transition-less stiffened cannula access set with the outer catheter was returned for investigation.The hub was separated from the outer catheter.The length of the catheter was measured.No excessive flash, discoloration, and deformities pinched or smashed tubing around the proximal end were noted.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Numerous design verification and validation activities have been performed to ensure that this device meets design requirements.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 were two other complaints to document this event for this lot number.This report includes information known at this time. a follow-up report will be submitted should additional relevant information become available.

• Brand Name: MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
• Type of Device: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7039369
• MDR Text Key: 92305857
• Report Number: 1820334-2017-03896
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00827002480025
• UDI-Public: (01)00827002480025(17)200609(10)7981134
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 03/22/2018

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: MPIS-401-10.0-SC-SST
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/30/2017
• Initial Date FDA Received: 11/16/2017
• Supplement Dates Manufacturer Received: 01/22/2018; 02/27/2018
• Supplement Dates FDA Received: 02/14/2018; 03/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention