MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 DILATION PRODUCTS

Device Problem Material Rupture (1546)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/22/2023

Event Type  Injury  

Event Description

It was reported that after successful deployment of an edwards sapien 3 valve in an 25mm edwards perimount valve in the pulmonic position, following serial dilation with a 28mm true balloon catheter, the balloon ruptured at the proximal balloon bond.The ruptured balloon was withdrawn to the level of the puncture site but was not able to be withdrawn through the skin.The deformed balloon profile was too large to safely pull through the skin.A vascular surgeon performed a cutdown to remove the true balloon and repair the femoral vein.A 14fr 85cm bbraun dville braided sheath was used during this procedure.There was no allegation of any edwards device that caused the event.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a: through f: the information provided by bd represents all 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.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all 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.H3 other text : the device was not returned.

Event Description

It was reported that after successful deployment of an edwards sapien 3 valve in an 25mm edwards perimount valve in the pulmonic position, following serial dilation with a 28mm true balloon catheter, the balloon ruptured at the proximal balloon bond.The ruptured balloon was withdrawn to the level of the puncture site but was not able to be withdrawn through the skin.The deformed balloon profile was too large to safely pull through the skin.A vascular surgeon performed a cutdown to remove the true balloon and repair the femoral vein.A 14fr 85cm bbraun dville braided sheath was used during this procedure.There was no allegation of any edwards device that caused the event.

Event Description

It was reported that after successful deployment of an edwards sapien 3 valve in an 25mm edwards perimount valve in the pulmonic position, following serial dilation with a 28mm true balloon catheter, the balloon ruptured at the proximal balloon bond.The ruptured balloon was withdrawn to the level of the puncture site but was not able to be withdrawn through the skin.The deformed balloon profile was too large to safely pull through the skin.A vascular surgeon performed a cutdown to remove the true balloon and repair the femoral vein.A 14fr 85cm bbraun dville braided sheath was used during this procedure.There was no allegation of any edwards device that caused the event.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be due to "poor balloon design (molecular orientation, wall thickness)".The device history record review could not be performed without a lot number.The product catalog number and the lot number for this device are unknown.Therefore, unable to determine the associated labeling to review.H11: section a through f - the information provided by bd represents all 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.H3 other text : the device was not returned.

• Brand Name: DILATION PRODUCTS
• Type of Device: DILATION PRODUCTS
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 18739230
• MDR Text Key: 335841828
• Report Number: 1018233-2024-00872
• Device Sequence Number: 1
• Product Code: FBW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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,Followup
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention; Other