MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW 6 FR 110 CM BALLOON WEDGE PRESSURE CATHE; CATHETER, FLOW DIRECTED

Model Number	IPN917225
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that " the balloon inflated but did not deflate during procedure".Additional information stated that the balloon was removed.The user reported "i tried again, to deflate it on the table, without success.Then, a few seconds later, it deflated on its own.Then it was impossible to re-inflate it".The patient's current condition is reported as "stable, no clinical consequences".It is unknown if another device was inserted.
Additional Manufacturer Narrative
(b)(4).The lot number reported is 16f23k0053.The lot number of the returned device is suspected to be from the reported lot; however, no original packaging/label was returned.Returned for investigation was a 6fr 110cm wedge catheter without the original packaging.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 1.0cc.Upon microscopic inspection, the balloon appeared typical; no damage or abnormalities were noted to the balloon.No condensation was noted within the inflation lumen extension line.Some dried blood/contrast media was noted within the injection lumen extension line.Spots of dried blood were noted on the exterior surfaces of the returned sample.No visual damage or abnormalities were noted to the returned sample.The inflation lumen was injected with 1.0cc of air using the returned control stroke syringe.The balloon inflated symmetrically.One side of the balloon measured approximately 5mm.The other side measured approximately 5mm.The balloon did meet specifications per graphic of radius ratio less than or equal to 1.5.The inflation lumen was injected with 1.0cc of air using the returned control stroke syringe.The balloon inflated symmetrically.The balloon deflated in less than 3 seconds when the syringe was removed per specification.No pull away was noted after the tug test.The balloon was placed in water and air were injected into the inflation lumen again.No leak was noted.The injection lumen was aspirated and flushed.Some dried blood specks were noted.A lab inventory 0.025in guidewire was back load-ed through the distal tip.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 inflated but did not deflate during procedure" is not confirmed.During the investigation, no damage or abnormalities were noted to the returned sample.After successful inflation, the balloon was successfully deflated per the specification.The returned device passed visual and functional test specifications.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint is undetermined.No further action required at this time.
Event or Problem Description
It was reported that " the balloon inflated but did not deflate during procedure".Additional information stated that the balloon was removed.The user reported "i tried again to deflate it on the table, without success.Then, a few seconds later, it deflated on its own.Then it was impossible to re-inflate it".The patient's current condition is reported as "stable, no clinical consequences".It is unknown if another device was inserted.

• Brand Name: ARROW 6 FR 110 CM BALLOON WEDGE PRESSURE CATHE
• 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: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21025844
• Report Number: 3010532612-2024-01141
• Device Sequence Number: 8995062
• Product Code: DYG
• UDI-Device Identifier: 00801902002877
• UDI-Public: (01)00801902002877(11)231030(17)250331(10)16F23K0053(21)
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K892530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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: 03/31/2025
• Device Model Number: IPN917225
• Device Catalogue Number: AI-07126
• Device Lot Number: 16F23K0053
• 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: Not provided
• Supplement Date Received by Manufacturer: 01/10/2025
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2023
• 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