MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DOT PROV SP 3F SL MAX; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2024
Type of Reportable Event	Malfunction
Additional 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 device has not been returned to the manufacturer for evaluation.
Event or Problem Description
It was reported that the peel away introducers are weak and keep having difficulty placing them and they mushroom out and fall apart where dilator meets sheath.No other information was provided.A specific number of affected devices or patients was not provided by the complainant.
Additional 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 complaint of a damaged microintroducer sheath is confirmed and was determined to be use related.One 3.5 fr galt microintroducer was returned for evaluation.An initial visual observation showed use residue on the returned sample.The distal tip of the sheath of the microintroducer was observed to be damaged.The dilator was observed to be slightly bent at the location of the damaged sheath tip.Some evidence of buckling was observed in the sheath about an inch proximal to the observed damage.A microscopic observation revealed the distal tip of the sheath to be plastically deformed with multiple tears and buckling of the edges of the sheath.The taper and radius of the distal end of the sheath appeared to have been properly formed prior to the plastic deformation.The shape, location, and extent of the damage observed on the returned sample suggest the microintroducer sheath was most likely damaged due to excessive insertion force, an inadequate skin nick, and/or a steep insertion angle.This complaint will be recorded for future trending and monitoring purposes.H3 other text : evaluation findings are in section h11.
Event or Problem Description
It was reported that the peel away introducers are weak and keep having difficulty placing them and they mushroom out and fall apart where dilator meets sheath.No other information was provided.A specific number of affected devices or patients was not provided by the complainant.

• Brand Name: DOT PROV SP 3F SL MAX
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• 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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 18717930
• Report Number: 3006260740-2024-00566
• Device Sequence Number: 11858968
• Product Code: LJS
• UDI-Device Identifier: 00801741134104
• UDI-Public: (01)00801741134104
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K162443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2024

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 Expiration Date: 10/31/2024
• Device Model Number: N/A
• Device Catalogue Number: S1173108PD
• Device Lot Number: REHS4276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2024
• Supplement Date Received by Manufacturer: 04/17/2024
• Initial Report FDA Received Date: 02/15/2024
• Supplement Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown