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

Catalog Number MPIS-401-10.0-SC-NT-SST

Device Problems Material Separation (1562); Split (2537)

Patient Problem No Code Available (3191)

Event Date 01/15/2018

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

It was reported that during a cerebral angiogram, the micropuncture transitionless stiffened cannula access set coaxial catheter broke in half inside of the patient's anatomy.The portion of the catheter with the tip remained on the wire guide being utilized.Access was obtained from the other side in order to cut down and successfully retrieve the broken catheter portions.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional/ corrected information: narrative = per information received on 26jan2018, the patient's anatomy was reported to be heavily scarred but not tortuous or calcified.This report includes information known at this time. a follow-up report will be submitted should additional relevant information become available.

Manufacturer Narrative

Device code: split (2537).A review of the dimensional verification, complaint history, device history record, drawing, manufacturing instructions, quality control, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that it separated as reported, at a distance which was measured to be 2.9 cm from the proximal hub.There was stretching noted on both separated segments of the device.Some wrinkling and a split at the tip were also noted.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there was one other reported complaint for this lot number.Based on the information provided, the examination of the returned product, 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.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.Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Device code: split (2537).A review of the dimensional verification, complaint history, device history record, drawing, manufacturing instructions, quality control, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that it separated as reported, at a distance which was measured to be 2.9 cm from the proximal hub.There was stretching noted on both separated segments of the device.Some wrinkling and a split at the tip were also noted.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there was one other reported complaint for this lot number.Based on the information provided, the examination of the returned product, 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.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 STIFFENED CANNULA ACCESS SET
• Type of Device: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7222934
• MDR Text Key: 98406446
• Report Number: 1820334-2018-00173
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00827002480032
• UDI-Public: (01)00827002480032(17)201121(10)8393541
• Combination Product (y/n): N
• 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: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2018
• 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-NT-SST
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 80