MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 UNIVERSAL MICROINTRODUCER KIT PTFE PEEL-APART SHEATH INTRODUCER 4.5FX5CM; INTRODUCER, CATHETER

Model Number N/A

Device Problem Material Deformation (2976)

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

Event Date 12/09/2021

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of redw1338 showed two other similar product complaint(s) from this lot number.

Event Description

It was reported that when inserting the microintroducer into the patient, the operator found its edges were uneven, unable to continue puncturing.Therefore, the microintroducer was removed and replaced with a new one.

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, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a damaged microintroducer is confirmed but the exact cause remains unknown.One 4.5 fr microez microintroducer was returned for evaluation.The grey sheath had not been peel and was returned with the dilator present.Blood residue was visible within the device.Microscopic observation of the sheath tip revealed it to be bunched inwards with the orifice flared outwards.The bunching was present on two regions of the sheath tip.Additional deformation was also present along the shaft.Based on the damage observed, possible contributing factors include advancement against resistance and inadequate skin knick.The product instructions for use (ifu) states, ¿advance the small sheath and dilator together as a unit over the guidewire, using a slight rotational motion.If necessary, a small incision may be made adjacent to the guidewire to facilitate insertion of the sheath and dilator.Verify institutional guidelines concerning the use of a scalpel prior to making incision.¿ since the sheath tip was observed to be damaged, the complaint is confirmed but the exact cause remains unknown.H3 other text : evaluation findings are in section h.11.

Event Description

It was reported that when inserting the microintroducer into the patient, the operator found its edges were uneven, unable to continue puncturing.Therefore, the microintroducer was removed and replaced with a new one.

• Brand Name: UNIVERSAL MICROINTRODUCER KIT PTFE PEEL-APART SHEATH INTRODUCER 4.5FX5CM
• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 13077943
• MDR Text Key: 282776746
• Report Number: 3006260740-2021-05407
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00801741048333
• UDI-Public: (01)00801741048333
• 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: 02/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• 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: REDW1338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2022
• 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