MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. FOLEY CATHETERS; CATHETER, RETENTION TYPE, BALL

Model Number	IPN050127
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Reported issue: a balloon catheter would not deflate even though it had been tested before the procedure.This is the first time this has ever happened at the clinic.It caused distress and dissatisfaction for our client.The patient's condition was reported as fine.
Additional Manufacturer Narrative
(b)(4) the device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
Reported issue: a balloon catheter would not deflate even though it had been tested before the procedure.This is the first time this has ever happened at the clinic.It caused distress and dissatisfaction for our client.The patient's condition was reported as fine.
Additional Manufacturer Narrative
(b)(4).The event occurred in canada and the report source was updated.There was no actual complaint sample returned for further investigation therefore, no physical assessment could be conducted only a document review.Based on the complaint description it was reported that the balloon was not deflated.Non deflation could be due to various reasons such as improper fixation of syringe to the valve, faulty valve, and blockage of inflation lumen.An empty syringe without plunger is recommended to be used to drain off the fluid by gravity and avoid creation of vacuum effect and ease deflation process.It is also mentioned in the ifu to aspirate the syringe gently to remove the inflation fluid, and do not use excessive aspiration on the syringe during deflation as this may cause a vacuum collapse of the inflation lumen.Besides that, non-deflation could also happen due to asymmetrical condition of the balloon which may result in occlusion of the inflation lumen eye during deflation process.However, since no actual or representative sample returned, the asymmetry ratio could not be measured where the acceptable limit for balloon asymmetry is based on 1:3 per internal requirement of qas-a001: quality assurance in current standard operating procedure as per spm-a51-003, the products are subjected to 100% visual inspection and any defective raw balloon will be culled out before sent to the next process.Upon completion of assembly process, the finished catheter will be again subjected to 100% balloon inspection and 20 minutes leak test (spm-a52-004).Catheter with defective balloon will be culled out.In conclusion, the balloon could not be deflated may be due to several reasons.Since there was no actual sample returned for this complaint, any further investigation was not possible.Thus, this complaint cannot be confirmed.

• Brand Name: FOLEY CATHETERS
• Common Device Name: CATHETER, RETENTION TYPE, BALL
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• Manufacturer (Section G): TELEFLEX MEDICAL SDN. BHD.; lot no : pt2577 jalen perusahaan; 4 kamunting industrial estate; perak, west malaysia 34600 ; MY 34600
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 15956149
• Report Number: 8040412-2022-00327
• Device Sequence Number: 7341535
• Product Code: EZL
• UDI-Device Identifier: 24026704307979
• UDI-Public: 04026704307975
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K972184
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2022

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 Model Number: IPN050127
• Device Catalogue Number: 170003080
• Device Lot Number: KME22C0718
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2022
• Supplement Date Received by Manufacturer: 12/22/2022
• Initial Report FDA Received Date: 12/10/2022
• Supplement Report FDA Received Date: 12/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2022
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown