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

Model Number IPN000074

Device Problem Material Puncture/Hole (1504)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

It was reported by (b)(6) lab at (b)(6) hospital.It was reported that balloon burst while in use.Three follow up attempts were made to obtain additional information regarding the patient condition and if the device is available for return but they were unsuccessful.If we received additional information, the complaint file will be updated.

Manufacturer Narrative

Qn#(b)(4).The product was not returned for investigation.The reported complaint that the "balloon burst while in use" is not able to be confirmed.If the product is returned at a later date, a full investigation of the sample will be completed.The root cause of the complaint 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 risk.This will be monitored for any developing trends.

Event Description

It was reported by kenneth gaines supply coor caradic cath lab at texas childrens hospital.It was reported that balloon burst while in use.Three follow up attempts were made to obtain additional information regarding the patient condition and if the device is available for return but they were unsuccessful.If we received additional information, the complaint file will be updated.

• Brand Name: CATH PKGD: WEDGE 7 FR 110 CM
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 12129837
• MDR Text Key: 260311210
• Report Number: 3010532612-2021-00189
• Device Sequence Number: 1
• Product Code: DYG
• UDI-Device Identifier: 00801902002884
• UDI-Public: 00801902002884
• Combination Product (y/n): N
• PMA/PMN Number: K892530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: IPN000074
• Device Catalogue Number: AI-07127
• Device Lot Number: 16F21B0160
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1