MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 UNIVERSAL MICROINTRODUCER KIT PFTE PEEL-APART SHEATH; INTRODUCER, CATHETER

Model Number N/A

Device Problem Material Frayed (1262)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/29/2022

Event Type  malfunction  

Event Description

It was reported that the guidewire was forked so that cannot be used.Patient status/ intervention: change new wire.No other information was provided.

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.Device not returned for evaluation.

Manufacturer Narrative

The information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged guidewire is inconclusive due to the state of the returned sample.One 4.5 fr x 5 cm microintroducer was returned for evaluation.An initial visual observation showed some use residue on the returned sample.The distal tip of the dilator was observed to be damaged.No damage was observed on the sheath.No guidewire was returned with the microintroducer.A microscopic observation revealed the edges of the dilator tip were rough, uneven, and plastically deformed.Some whitening of the material around the damage on the dilator tip was observed, and one edge of the dilator tip was observed to flare outward.While damage was found on the returned microintroducer that could have been caused by difficulties in threading a guidewire through the dilator, the alleged failure of a damaged guidewire could not be confirmed as no guidewire was returned for evaluation.Therefore, this complaint is inconclusive at this time.A lot history review (lhr) of (b)(4) showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the guidewire was forked so that cannot be used.Patient status/ intervention: change new wire.No other information was provided.

• Brand Name: UNIVERSAL MICROINTRODUCER KIT PFTE PEEL-APART SHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 14456666
• MDR Text Key: 292221464
• Report Number: 3006260740-2022-01840
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K915167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/23/2022

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0668945
• Device Lot Number: REFS3027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/29/2022
• Initial Date FDA Received: 05/20/2022
• Supplement Dates Manufacturer Received: 08/23/2022
• Supplement Dates FDA Received: 08/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2021
• 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 Outcome(s): Other