MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 UNIVERSAL MICROINTRODUCER KIT PTFE PEEL-APART SHEATH INTRODUCER 4.5F X 5CM; INTRODUCER, CATHETER

Model Number N/A

Device Problems Material Frayed (1262); Difficult to Remove (1528); Material Rupture (1546)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/24/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of recx0428 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that a after the guidewire placement, the device allegedly unable to remove.Therefore under dsa (digital subtraction angiography) the guidewire was bifurcated, ruptured in the body and removed by interventional method.The patient status was unknown.

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 batch history, labeling, applicable manufacturing records, sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a break in the guidewire was confirmed and appears to have occurred during use.The product returned for evaluation was a guidewire in two pieces.There was a break in both the core and coil wires.The core wire was approximately 13.2¿ long on the proximal piece and 0.6¿ long on the distal piece.The coil wire on both the proximal and distal segments was elongated and tangled.Microscopic examination of the break site revealed that the core wire was curled just proximal and distal of the break site.The break site contained a flat fracture plane on both the core and coil wires.Tactile evaluation confirmed the presence of multiple kinks along the proximal piece of the guidewire; 5.0¿, 8.1¿, 9.8¿ and 12.3¿ from the proximal end.A more severe kink was felt 12.7¿ from the proximal end (approximately 0.5¿ proximal of the break site).Tactile evaluation of the distal piece also revealed a kink 0.3¿ from the distal end (0.3¿ distal of the break site).The damage seen on the returned guidewire is consistent with the guidewire being retracted back through the needle and shearing on the needle bevel.As per the device ifu, ¿caution: if the guidewire must be withdrawn while the needle is inserted, remove both the needle and wire as a unit to prevent the needle from damaging or shearing the guidewire.¿ h3 other text : evaluation findings are in section h11.

Event Description

It was reported that a after the guidewire placement, the device allegedly unable to remove.Therefore under dsa (digital subtraction angiography) the guidewire was bifurcated, ruptured in the body and removed by interventional method.The patient status was unknown.

• Brand Name: UNIVERSAL MICROINTRODUCER KIT PTFE PEEL-APART SHEATH INTRODUCER 4.5F X 5CM
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 10707764
• MDR Text Key: 212264762
• Report Number: 3006260740-2020-20188
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• PMA/PMN Number: K915167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 0668945
• Device Lot Number: RECX0428
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Date Manufacturer Received: 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR