MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC CATH PKGD: BERMAN 7 FR 110CM; CATHETER, FLOW DIRECTED

Model Number	IPN923531
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the balloon passed the inflation test prior to use, however the balloon ruptured inside the patient while in use.As a result, the balloon was removed and a 2nd iab was inserted at the same insertion site.No harm or injury to the patient.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The reported lot number (16f22g0083) matches the lot number on the returned teleflex japan label.Returned for investigation was a 7fr.110cm berman catheter with a portion of the original packaging pouch including the teleflex japan label.Upon return, the supplied control stroke syringe was noted connected to the inflation lumen stopcock; no damage or abnormalities were noted to the returned syringe.The inflation lumen stopcock was in the open position.The recommended volume capacity of the balloon is 1.25cc.Upon microscopic inspection, the catheter balloon was immediately noted ruptured/torn; the balloon was noted partially attached to the catheter extrusion near the distal tip of the catheter.Dried contrast media was noted in the injection lumen extension line.No condensation was noted in the inflation lumen extension line.Spots of dried blood were noted on the exterior surfaces of the returned sample.No blood was noted within the interior surfaces of the returned sample.No other damage or abnormalities were noted to the returned sample.The symmetry of the balloon could not be measured due to the returned state of the device.The balloon could not be functi onally tested due to the returned state of the device.The balloon damage was previously confirmed near the distal tip of the catheter.The cause of the ruptured/torn balloon cannot be determined.The injection lumen was aspirated and flushed.No blood or debris was noted.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.The risk is acceptable.This will be monitored for any developing trends.The reported complaint that the "balloon got ruptured in the patient while in use" is confirmed.The catheter balloon was found ruptured/torn upon receipt of the sample.The cause of the ruptured/torn balloon could not be confidently determined.Based on a review of the device history record (dhr), the product met specification upon release; however, the specifications were not met during the complaint investigation due to the ruptured/torn balloon.The root cause of the complaint is undetermined.No further action required at this time.This will be monitored for any developing trends.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that the balloon passed the inflation test prior to use, however the balloon ruptured inside the patient while in use.As a result, the balloon was removed and a 2nd iab was inserted at the same insertion site.No harm or injury to the patient.The patient status is reported as "fine".

• Brand Name: CATH PKGD: BERMAN 7 FR 110CM
• Common Device Name: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 16387817
• Report Number: 3010532612-2023-00105
• Device Sequence Number: 20260384
• Product Code: DYG
• UDI-Device Identifier: 10801902206678
• UDI-Public: 10801902206678
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K892530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2023

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: 12/31/2023
• Device Model Number: IPN923531
• Device Catalogue Number: AI-07137
• Device Lot Number: 16F22G0083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2023
• Supplement Date Received by Manufacturer: 03/30/2023
• Initial Report FDA Received Date: 02/16/2023
• Supplement Report FDA Received Date: 03/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown