MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT PFLEX, 18G 10CM FULL (POWERGLIDE PRO); INTRAVASCULAR CATHETER

Catalog Number F118101

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

The information provided by bard 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 bard.The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a damaged powerglide flex catheter was confirmed and the damage appears to be use related.One 18ga powerglide flex catheter and deployment system were returned for investigation.The returned sample revealed evidence of use.Blood residue was observed throughout the sample.The needle was bent at the point it extends from the housing.The catheter had not been removed from the needle.The guidewire push-off button and the catheter wings had not been deployed.The needle breached the catheter 1.2cm from the distal tip of the catheter.2.3cm of guidewire were protruding from the hole in the catheter where the needle had penetrated.The distal tip of the guidewire was located in the distal end of the catheter.The guidewire was removed from the catheter and the overall length of the guidewire segment was 2.9cm.The coil wire was not elongated.A microscopic examination of the 2.9cm guidewire segment revealed that the weld tip was present at the distal tip.The proximal end of the guidewire segment revealed that it had been sheared.The inner edge of the needle bevel revealed deformation and impressions that are consistent with the guidewire coils.The damage appears to be consistent with needle tip damage.The catheter was most likely punctured with the needle and the guidewire most likely sheared against the needle bevel.The damage observed on the returned device is consistent with damage associated with use.This can occur by re-inserting the needle back into the catheter or pulling the catheter back over the needle during the placement process.No further action is required because the complainant event could not be related to a deficiency in product manufacture or deficiency while under correct product use.The product ifu warns, ¿once the catheter has been advanced, do not re-insert the needle back into the catheter or pull the catheter back onto the needle.This may result in damage to the catheter.If the catheter needs to be repositioned, either do so without the aid of the needle, or remove both the catheter and the needle as a unit to prevent the needle from damaging or shearing the catheter.¿ the ifu also states, ¿do not perforate, tear, or fracture the catheter with the needle or guidewire during the procedure.¿ a lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

Per sales representative, the facility reported that the device "malfunctioned".It was stated that during placement the catheter sheared and became stuck in the patient's tissue.The catheter fragment was left in the patient's tissue.No long-term or permanent impairment to the patient was reported.

• Brand Name: DOT PFLEX, 18G 10CM FULL (POWERGLIDE PRO)
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: teresa johnson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225435
• MDR Report Key: 6248283
• MDR Text Key: 64713935
• Report Number: 3006260740-2016-00725
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741110566
• UDI-Public: (01)00801741110566
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: F118101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/27/2016
• Initial Date FDA Received: 01/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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