MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC CATH PKGD: WEDGE 6 FR 110 CM; CATHETER, FLOW DIRECTED

Model Number	IPN923527
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, " balloon deflated spontaneously after insertion, a second device was used and the procedure was completed".Additional information states the 2nd iab was inserted at the same insertion site.Patient condition is reported as "fine".
Event or Problem Description
It was reported that, "balloon deflated spontaneously after insertion, a second device was used and the procedure was completed".Additional information states the 2nd iab was inserted at the same insertion site.Patient condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The reported lot number (16f22g0005) matches the lot number on the returned packaging pouch.Returned for investigation was a 6fr.Wedge 110cm catheter with its original packaging pouch.Upon return, the supplied control stroke syringe was 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 1.0cc.No condensation was noted in the inflation lumen extension line.No contrast media was noted within injection lumen extension line.Spots of dried blood was noted on the exterior surfaces of the returned sample.Dried blood was noted on the interior surfaces of the balloon/on the distal tip extrusion.Under microscopic inspection, the balloon appeared typical; however, a crack/damage was noted on the epoxy bond and catheter extrusion beneath the latex balloon near the distal tip; the total length of the crack is approximately 2mm.No other damage or abnormalities were noted to the returned sample.The balloon did not stay inflated during the inflation test due to the cracked catheter extrusion beneath the latex balloon; therefore, the symmetry of the balloon could not be measured.The balloon was injected with 1.0cc of air using the returned control stroke syringe.The balloon was fully inflated; however, the balloon deflated within 3 seconds.The balloon was placed in water, and air was injected into the inflation lumen.A leak was apparent from the distal tip of the catheter.The leak is a result of the previously noted cracked distal tip extrusion.The appearance of crack is consistent with damage to the adhesive/epoxy bond and catheter extrusion.The injection lumen was aspirated and flushed.No blood or debris was noted.Upon further testing, the distal tip of the catheter was blocked off and air was injected through the injection lumen extension luer, the balloon started inflating.This is consistent with the cracked distal tip extrusion.A lab inventory 0.025in guidewire was back loaded through the distal tip.No resistance was noted; the guidewire was able to advance through the injection lumen.No blood or debris was noted.The guidewire was front loaded through the injection extension line.No resistance was noted; the guidewire was able to advance through the injection lumen.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 reported complaint that the "balloon deflated spontaneously after insertion" is confirmed.During the investigation, a leak was noted from the distal tip of the catheter upon balloon inflation.A crack to the catheter extrusion and adhesive/epoxy bond was noted at the distal tip of the catheter causing the leak.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 cracked distal tip extrusion.The probable root cause of the complaint is manufacturing related.Other remarks: n/a.Corrected data: n/a.

• Brand Name: CATH PKGD: WEDGE 6 FR 110 CM
• 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: 16408761
• Report Number: 3010532612-2023-00093
• Device Sequence Number: 5759397
• Product Code: DYG
• UDI-Device Identifier: 10801902206746
• UDI-Public: 10801902206746
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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): 02/02/2023

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: IPN923527
• Device Catalogue Number: AI-07126
• Device Lot Number: 16F22G0005
• 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: 02/02/2023
• Supplement Date Received by Manufacturer: 04/03/2023
• Initial Report FDA Received Date: 02/21/2023
• Supplement Report FDA Received Date: 04/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2022
• 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