MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR PERCUTANEOUS SHEATH INTRODUCER SET; CATHETER, PERCUTANEOUS

Model Number I301F6

Device Problem Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/26/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation; it was discarded at the hospital.Without return of the unit it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.It is not known if some procedural factors may have contributed to the event.No corrective actions will be taken at this time.A review of the manufacturing records indicated that the product met specifications upon release.Invasive procedures involve some patient risks.Although serious complications are relatively uncommon, the physician is advised, before deciding to insert or use the introducer, to consider the potential benefits in relation to the possible complications.The techniques for insertion and the occurrence of complications is well described in the literature.In this case, the patient required a new stick to insert a new guidewire.It is unknown if user or procedural factors may have contributed to this event.A 100% visual inspection is performed to all wires to ensure that it meets the following conditions: free of kinks, bump free, are not frayed, are not stretched or exposed and the end or tip must be in the shape of a j.It should be noted that the ifu covers the correct insertion and handling of the guidewire.It specifies that the guidewire should never be forced and if difficulty is met during insertion, completely withdraw the guidewire and reattempt insertion.Also, a "caution note" indicates to avoid possible severing of the guidewire, do not withdraw the guidewire against the needle bevel.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.

Event Description

As reported, when inserting this introducer into an (b)(6) year-old male patient, there was resistance with the guidewire.The device had to be removed and a new puncture was needed to continue.There was no allegation of patient injury.The device was not available for evaluation.

• Brand Name: PERCUTANEOUS SHEATH INTRODUCER SET
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: jessica atallah ; 1 edwards way; irvine, CA 92614 ; 9492502904
• MDR Report Key: 10538653
• MDR Text Key: 207937085
• Report Number: 2015691-2020-13573
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K831729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/06/2020
• Device Model Number: I301F6
• Device Lot Number: 61719671
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Weight: 90