MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CATH PKGD: BERMAN 4 FR 50CM; CATHETER, FLOW DIRECTED

Catalog Number	AI-07134
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that the catheter was injected at 600psi and the balloon lumen syringe backed up and they heard a pop (assumed it was balloon which should not be affected when injecting dye) so the device was immediately removed.There was no report of patient complication or serious injury and death.
Event or Problem Description
It was reported that the catheter was injected at 600psi and the balloon lumen syringe backed up and they heard a pop (assumed it was balloon which should not be affected when injecting dye) so the device was immediately removed.There was no report of patient complication or serious injury and death.
Additional Manufacturer Narrative
(b)(4).Teleflex received the device for investigation.The reported complaint of balloon would not inflate in use is confirmed.Upon functional testing, the inflation lumen was found blocked and was caused by a dried blood clot noted within the inflation lumen.No damage was noted to the balloon.No inter lumen crossover was noted between the inflation lumen and the injection lumen.The root cause of how blood entered the inflation lumen 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.

• Brand Name: CATH PKGD: BERMAN 4 FR 50CM
• Common Device Name: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8401241
• Report Number: 3010532612-2019-00071
• Device Sequence Number: 2029643
• Product Code: DYG
• UDI-Device Identifier: 00801902002266
• UDI-Public: 00801902002266
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K892530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2019

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: 06/30/2019
• Device Catalogue Number: AI-07134
• Device Lot Number: 16F18B0097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2019
• Initial Date Received by Manufacturer: 02/14/2019
• Supplement Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 03/07/2019
• Supplement Report FDA Received Date: 04/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1