MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 UNIVERSAL MICROINTRODUCER KIT PTFE PEEL-APART SHEATH INTRODUCER 4.5F; INTRODUCER, CATHETER

Model Number N/A

Device Problems Material Frayed (1262); Defective Component (2292)

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

Event Date 08/12/2021

Event Type  malfunction  

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged guidewire was confirmed; however, the root cause was not identified.The product returned for evaluation was one photograph which depicted a guidewire.The depicted region of the guidewire included one end.Usage residues appeared to be evident near the tip.The guidewire appeared slightly deformed near the tip.While guidewire deformation was visible in the submitted photograph, inspection of the photograph was insufficient to identify the cause of the deformation.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.Potential contributing factors include guidewire manipulation and withdrawal against the needle bevel.A lot history review (lhr) of redw3490 showed one other similar product complaint(s) from this lot number.

Event Description

It was reported that during placement of the catheter, after the guide wire was inserted into the introducer needle, the (b)(4) introduction sheath was entered.When the introducer needle was withdrawn, it was strongly felt that the guide wire was also taken out by a portion.Resistance was encountered when the dilator was inserted through the guide wire.After the catheter placement was completed, the guide wire was checked and burrs (a small portion of metal bump) were found with the distal end of the guide wire.

Manufacturer Narrative

H11: section a through f - 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), labeling, 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 confirmed; however, the exact cause is unknown.One 0.018 in.Guidewire was returned for evaluation.An initial visual observation showed the returned guidewire was curved and bent in at least two locations.A microscopic observation revealed usage residues on the returned sample.The coiled wire at the proximal tip of the guidewire was found to be disjointed and broken near the weld tip.The core wire of the guidewire was found to be intact and both weld tips of the guidewire were present and intact.The break in the coiled wire was observed to be mostly flat and appeared to be granular in texture.While the exact cause of the damage observed in the returned guidewire could not be determined, possible causes include damage during packaging, handling, or use.H3 other text : evaluation findings are in section h.11.

Event Description

It was reported that during placement of the catheter, after the guide wire was inserted into the introducer needle, the 0668945 introduction sheath was entered.When the introducer needle was withdrawn, it was strongly felt that the guide wire was also taken out by a portion.Resistance was encountered when the dilator was inserted through the guide wire.After the catheter placement was completed, the guide wire was checked and burrs (a small portion of metal bump) were found with the distal end of the guide wire.

• Brand Name: UNIVERSAL MICROINTRODUCER KIT PTFE PEEL-APART SHEATH INTRODUCER 4.5F
• 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: kelsey erickson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 12488322
• MDR Text Key: 271911126
• Report Number: 3006260740-2021-03853
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K915167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2021
• 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: REDW3490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2019
• 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