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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/26/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient age at time of event was not provided.Patient sex at time of event was not provided.(b)(4).This event is currently under investigation.
Event or Problem Description
Per voluntary report mw5061023: the inner catheter of the micropuncture set separated, leaving half in the patient.The catheter was snared and removed.Additional information was provided stating: the patient had a large left neck tumor (metastatic stage 4 ca w/lung) that had persistent bleeding-oozing.The patient had 2 prior embolizations of carotid artery and was stable, then it began oozing again.It was necessary to sacrifice the left vertebral artery.During the right groin puncture, the micropuncture "got caught up in right groin and sheared off 4 inches of catheter with the distal end still remaining within the vessel.The left groin was accessed and a gooseneck was used to snare the wire and catheter at the arteriotomy site.Per voluntary report mw5061023: distal end still in vessel.It is unknown if there have been any adverse effects at this time.Additional information has been requested but not yet provided by the reporter.
Additional Manufacturer Narrative
(b)(4).Investigation/evaluation: during the course of the investigation a review of the complaint history, quality control, device history record, instructions for use (ifu),specifications and a verification of the returned device were conducted.The complaint device was stretched and separated 2.2 cm from the proximal hub.The separated piece was bent and kinked approximately 2.5 cm distal to the separation.The angle of the bend was about 48 degrees.There was an additional bend 3 cm distal to the kink.This bend was noted to be about 30 degrees.After reviewing the complaint device it was possible to determine that the device was subjected to force beyond its intended design during the procedure.The bends and kink in the outer catheter shaft as well as the stretching at the separation of the outer catheter point to this as the likely scenario in this case.We will continue to monitor for similar complaints.Per the quality engineering risk assessment, no further action is required.(b)(4).
Event or Problem Description
Per voluntary report mw5061023: the inner catheter of the micropuncture set separated, leaving half in the patient.The catheter was snared and removed.Additional information was provided stating: the patient had a large left neck tumor (metastatic stage 4 ca w/lung) that had persistent bleeding-oozing.The patient had 2 prior embolizations of carotid artery and was stable, then it began oozing again.It was necessary to sacrifice the left vertebral artery.During the right groin puncture, the micropuncture "got caught up in right groin and sheared off 4 inches of catheter with the distal end still remaining within the vessel.The left groin was accessed and a gooseneck was used to snare the wire and catheter at the arteriotomy site.Per voluntary report mw5061023: distal end still in vessel.It is unknown if there have been any adverse effects at this time.Additional information has been requested but not yet provided by the reporter.

• Brand Name: MICROPUNCTURE TRANSITIONLESS ACCESS SET
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5636785
• Report Number: 1820334-2016-00306
• Device Sequence Number: 16274220
• Product Code: DYB
• UDI-Device Identifier: 00827002479494
• UDI-Public: (01)00827002479494(17)181218(10)6467965
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2016
• Report Date (Section F): 03/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: MPIS-401-U-SST
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/26/2016
• Device Age: 5 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/06/2016
• Supplement Report FDA Received Date: 08/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 03/08/2016