MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CATH PKGD: WEDGE 7 FR 110 CM; CATHETER, FLOW DIRECTED

Catalog Number	AI-07127
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the doctor had attempted to use an arrow balloon wedge pressure catheter on a patient.He did insert it into the patient, it inflated partially, and however, it would not deflate.No complications to the patient were incurred.It possibly ruptured upon removal because it was deflated when it came out.When he re-attempted to re-inflate outside of the patient, it inflated partially but not fully." there was no reported patient death, serious injury or complications.
Additional Manufacturer Narrative
(b)(4).Teleflex received the device for investigation.The reported complaint that the balloon would not inflate in use is confirmed.Upon return, the inflation syringe was found connected to the injection extension line.The correct extension line to connect the inflation syringe is the inflation extension line.The returned device passed functional test specification.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.An in-service for the customer will be performed to reiterate the appropriate method for the correct usage of the inflation syringe.
Event or Problem Description
It was reported that "the doctor had attempted to use an arrow balloon wedge pressure catheter on a patient.He did insert it into the patient, it inflated partially, and however, it would not deflate.No complications to the patient were incurred.It possibly ruptured upon removal because it was deflated when it came out.When he re-attempted to re-inflate outside of the patient, it inflated partially but not fully." there was no reported patient death, serious injury or complications.

• Brand Name: CATH PKGD: WEDGE 7 FR 110 CM
• Common Device Name: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7736143
• Report Number: 3010532612-2018-00231
• Device Sequence Number: 14145944
• Product Code: DYG
• UDI-Device Identifier: 00801902002884
• UDI-Public: 00801902002884
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K892530
• 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): 07/04/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: AI-07127
• Device Lot Number: 16F18E0092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2018
• Initial Date Received by Manufacturer: 07/04/2018
• Supplement Date Received by Manufacturer: 08/29/2018
• Initial Report FDA Received Date: 07/31/2018
• Supplement Report FDA Received Date: 08/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1