MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. TRANSRADIAL ACCESS TRAY; INTRODUCER CATHETER

Catalog Number	AA-10611-1
Medical Device Problem Codes	Entrapment of Device (1212); Material Separation (1562)
Health Effect - Clinical Code	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	08/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "uncomplicated puncture of the radial artery.Difficulties to insert the sheath through the skin.Consequently, sending off the tip after the incision resistance to push the sheath.After pushing the sheath guidewire was broke." it was reported that the device was removed.Another device was used via a different entrance.It was also reported that the patient did require an intervention to remove the piece of the guidewire that broke off."the surgeon cut the skin and vessel open to remove the device".Patient current condition reported as fine.There was no report of patient death.
Additional Manufacturer Narrative
(b)(4).Teleflex received the device for investigation.The reported complaint of swg damaged/separated is confirmed.The swg was returned with significant unraveling and damage.The root cause of the unraveling/damaged swg is undetermined.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revised risks.This will be monitored for any developing trends.No further action required at this time.Other remarks: additional information was obtained from the healthcare provider.It was reported that the device was removed in its entirety.A new device was placed.The patient outcome reported as okay and the procedure was a success in the end.There was no harm done.
Event or Problem Description
It was reported "uncomplicated puncture of the radial artery.Difficulties to insert the sheath through the skin.Consequently, sending off the tip after the incision resistance to push the sheath.After pushing the sheath guidewire was broke." it was reported that the device was removed.Another device was used via a different entrance.It was also reported that the patient did require an intervention to remove the piece of the guidewire that broke off."the surgeon cut the skin and vessel open to remove the device".Patient current condition reported as fine.There was no report of patient death.

• Brand Name: TRANSRADIAL ACCESS TRAY
• Common Device Name: INTRODUCER CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7890920
• Report Number: 3010532612-2018-00302
• Device Sequence Number: 16771116
• Product Code: DYB
• UDI-Device Identifier: 00801902066633
• UDI-Public: 00801902066633
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K112554
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2018

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 Expiration Date: 04/30/2020
• Device Catalogue Number: AA-10611-1
• Device Lot Number: 14F18D0401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2018
• Initial Date Received by Manufacturer: 09/10/2018
• Supplement Date Received by Manufacturer: 11/01/2018
• Initial Report FDA Received Date: 09/19/2018
• Supplement Report FDA Received Date: 11/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 63