MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER; CATHETER, EMBOLECTOMY

Model Number 12TLW405F35

Device Problems Deflation Problem (1149); Inflation Problem (1310); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/26/2019

Event Type  malfunction  

Manufacturer Narrative

Our product evaluation laboratory received one model 12tlw405f35 catheter with a 3ml syringe.A balloon inflation test was performed and back pressure was observed, indicating occlusion from the balloon inflation lumen.An unknown silvery material was observed in the inflation port and at the catheter tip.X-ray photo and cut down on the catheter body found the silver material to be a metal rod in the balloon inflation lumen, from the catheter tip to approximately 11cm from the catheter tip.The outer diameter of the metal rod was measured to be 0.0065 inches.Both the balloon and windings were intact.The through lumen was found to be patent and did not leak.No other visible damage or inconsistency was observed from the catheter body.The customer photos showed a shelf box of the reported model and what appeared to be the returned device in a biohazard bag.The customer report of a balloon inflation issue was confirmed on evaluation.A section of the unknown material was cut and sent to chemistry for further analysis.A supplemental report will be submitted with the findings upon completion.A device history record review was completed and documented that the device met all specifications upon distribution.Udi #: (b)(4).

Event Description

It was reported that in the middle of a procedure, the balloon on a fogarty catheter would not expand.It was exchanged for a new one.There was no patient injury.

Manufacturer Narrative

An engineering evaluation was initiated to assess for any manufacturing-related processes which could be correlated to the complaint.The complaint failure is confirmed as a manufacturing non-conformance and was replicated in the manufacturing area.The inflation mandrel was inserted in the 5.5f thrulumen catheter during the bushing assembly process.The inflation mandrel was left in the unit, and the ¿cut slot¿ and ¿cut tip¿ operation was performed.The tip forming operation was performed on the unit with the inflation mandrel inside the catheter, and the balloon winding process was performed.The unit was examined using an optical comparator and part of the inflation mandrel was observed in the tip.The balloon of the unit was inflated and the balloon inflated clear and concentric and no resistance was felt.The following root causes were retained: lack of instructions on the manufacturing process and inadequate process control.This is an isolated event and is the only complaint to have been evaluated and confirmed with the same failure mode during the last 12 months.A personnel acknowledgment was provided on to the manufacturing personnel on (b)(6) 2019 to notify them about the complaint.

Manufacturer Narrative

Chemistry analysis was performed on the section of the unknown material that was cut.Energy dispersive spectroscopy (eds) detected iron, chromium, iodine, nickel, manganese and silicon.Per engineering, as part of the catheter bushing assembly process for the thrulumen 5.5f products, a stainless-steel mandrel measuring 0.007 inches diameter is inserted in the inflation lumen.The wire found inside the complaint unit has a diameter of 0.0065 inches.The stainless-steel mandrel material is stainless steel-304 and iron, chromium, nickel, manganese, and silicone are components of stainless steel-304.Invasive procedures involve some patient risks.Although serious complications are relatively uncommon, the physician is advised, before deciding to insert or use the catheter, to consider the potential benefits in relation to the possible complications.The techniques for insertion, methods of using the catheter to obtain patient data information, and the occurrence of complications is well described in the literature.It is common clinical practice to check balloon integrity by inflating it to the recommended volume in order to detect any asymmetry or leakage condition before use of the catheter.This non-conformance involves a swan-ganz catheter that had a metallic rod present in the inflation lumen.The swan-ganz catheter is an intravenous device which goes to the pulmonary artery.If the balloon were to burst during use, the metal rod could embolize into the vasculature.Foreign material composed of metal has a higher potential for injury, such as vessel damage.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 8729152
• MDR Text Key: 149193661
• Report Number: 2015691-2019-02304
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• PMA/PMN Number: K892410
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/27/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: 12TLW405F35
• Device Catalogue Number: 12TLW405F35
• Device Lot Number: 61878426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2019
• Initial Date Manufacturer Received: 06/19/2019
• Initial Date FDA Received: 06/24/2019
• Supplement Dates Manufacturer Received: 06/28/2019; 08/23/2019; 07/23/2020
• Supplement Dates FDA Received: 07/08/2019; 08/26/2019; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1