MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CATH PKGD: BERMAN 6 FR 90CM; CATHETER, FLOW DIRECTED

Model Number	IPN000084
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that the md was performing the procedure according to the ifu.The md found that the balloon would not inflate due to a catheter defect.As a result, the md judged it as a defective product and another catheter was used at the same insertion site.There was no report of delay in therapy.There was no report of patient complications, serious injury or death.
Event or Problem Description
It was reported that the md was performing the procedure according to the ifu.The md found that the balloon would not inflate due to a catheter defect.As a result, the md judged it as a defective product and another catheter was used at the same insertion site.There was no report of delay in therapy.There was no report of patient complications, serious injury or death.
Additional Manufacturer Narrative
Qn# (b)(4).Teleflex received the device for investigation.The reported complaint of balloon would not inflate in use is not confirmed.No damage or abnormalities were noted to the returned sample upon receipt.The balloon inflated as per specifications during the investigation, and the returned device passed visual and functional test specifications.The root cause of the complaint is undetermined.A device history record (dhr) review was not performed.There was no confirmed product failure with the returned sample.Teleflex assessed the risk for the reported complaint.There are no new or revised risk.This will be monitored for any developing trends.

• Brand Name: CATH PKGD: BERMAN 6 FR 90CM
• Common Device Name: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 12120588
• Report Number: 3010532612-2021-00184
• Device Sequence Number: 19810845
• Product Code: DYG
• UDI-Device Identifier: 00801902002280
• UDI-Public: 00801902002280
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K892530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2021

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: 05/31/2021
• Device Model Number: IPN000084
• Device Catalogue Number: AI-07136
• Device Lot Number: 16F19M0098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2021
• Initial Date Received by Manufacturer: 06/07/2021
• Supplement Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 07/06/2021
• Supplement Report FDA Received Date: 07/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1