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

Catalog Number	AI-07126
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "the md was unable to pass the wire through the catheter.There was no harm to the patient".Additional information received states that there was no patient consequences, no medical intervention required, the current status of the patient is "unknown".
Event or Problem Description
It was reported that "the md was unable to pass the wire through the catheter.There was no harm to the patient".Additional information received states that there was no patient consequences, no medical intervention required, the current status of the patient is "unknown".
Additional Manufacturer Narrative
Qn# (b)(4).The reported complaint for "unable to pass the wire through the catheter" was not confirmed upon investigation of the returned sample.The customer returned a 6fr.Wedge 110cm catheter with the original packaging lidstock (inp-4) for investigation.The sample was returned in a cardboard box and was in a bio-hazard bag (inp-1, inp-2).Upon return, the supplied control stroke syringe was noted connected to the inflation lumen stopcock; no damage or abnormalities were noted to the returned control stroke syringe (inp-5).The inflation lumen stopcock was in the open position (inp-5, inp-6).The recommended volume capacity of the balloon is 1.0cc (inp-6).Upon microscopic inspection, the balloon appeared typical; no visual damage or abnormalities were noted to the balloon (inp-9).Upon inspection, no damage or obvious blockage was noted at the tip of the catheter (inp-8).Upon microscopic inspection, no blockage or abnormalities were noted to the distal opening of the injection lumen (inp-10).No visual damage or abnormalities were noted to the returned sample.No condensation was noted within the inflation lumen extension line.Dried blood was noted on the exterior surfaces of the catheter; dried/liquid blood was noted within the injection lumen extension line (inp-7).The inflation lumen was injected with 1.0cc of air using the returned control stroke syringe.The balloon inflated symmetrically (anp-1, anp-2).One side of the balloon measured approximately 4mm and the other side measured approximately 4mm.The balloon did meet specifications per graphic of radius ratio less than or equal to 1.5.Also, the balloon inflated symmetrically (anp-1, anp-2) and it 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 was injected into the inflation lumen again.No leak was noted.The injection lumen was aspirated and flushed.Dried blood was noted.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.Some blood 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.Based on a review of the device history record (dhr), the product met specification upon release.The returned device passed visual and functional test specifications.No further action was required at this time.Teleflex will continue to monitor and trend on complaints of this nature.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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 18519489
• Report Number: 3010532612-2024-00060
• Device Sequence Number: 20502263
• Product Code: DYG
• UDI-Device Identifier: 00801902002877
• UDI-Public: 00801902002877
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K892530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2024

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: 04/30/2025
• Device Catalogue Number: AI-07126
• Device Lot Number: 16F23L0004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2024
• Supplement Date Received by Manufacturer: 02/01/2024
• Initial Report FDA Received Date: 01/16/2024
• Supplement Report FDA Received Date: 02/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2023
• 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