MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DOT 3FR SL PROV ML; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	SP4153108DB
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 microintroducer is confirmed; however, the exact cause is unknown.One 3.5 fr x 7 cm microintroducer was returned for evaluation.An initial visual observation showed use residue on the returned sample.The distal tip of the sheath was observed to be damaged and an approximately 1 cm length of the sheath was observed to be buckled about 1 cm proximal to the sheath tip.The distal end of the dilator was observed to be bent.A microscopic observation revealed the distal tip of the introducer sheath was damaged and plastically deformed in multiple locations around its circumference.One edge of the tip of the introducer sheath was observed to be folded inward and over itself, and another edge of the tip was observed to be buckled.While the root cause of the damage observed on the introducer sheath is unknown, possible causes include damage during handling or use.A lot history review (lhr) of reep4196 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported microintroducer buckled when trying to insert.No other information was provided.(b)(6) 2021: it was found that the introducer sheath tip was flared and damaged on the returned sample.

• Brand Name: DOT 3FR SL PROV ML
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11474630
• Report Number: 3006260740-2021-00798
• Device Sequence Number: 16997510
• Product Code: PND
• UDI-Device Identifier: 00801741185076
• UDI-Public: (01)00801741185076
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K153393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/24/2021

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: SP4153108DB
• Device Catalogue Number: SP4153108DB
• Device Lot Number: REEP4196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2021
• Initial Report FDA Received Date: 03/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other